A Study to Assess the Safety, Tolerability and Pharmacokinetics of BSG005.

NCT04921254 | Unknown Phase 1 DMC

• 1 other identifier: BSG1.01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of BSG005 following single and multiple ascending doses in healthy subjects. The study will include a single ascending dose part and a multiple ascending dose part

Conditions

Invasive Fungal Infections

Outcome Measures

Primary Outcomes (1)

• AE recorded during and after BSG005 infusion

  The Investigator will carefully monitor each subject throughout the study for any AEs (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities \[MedDRA\])

  On single dose(-1 to 7 days) and multiple dosing (- 1 to 14 days) changes.

Secondary Outcomes (6)

• Pharmacokinetics of BSG005 infusion at different dose levels in SAD and MAD conditions

  24 hours.

• Cmax

  24 hours

• Tmax

  24 hours

• AUC (0-t)

  24 hours

• t1/2

  24 hours

Study Arms (2)

BSG005

EXPERIMENTAL

Active antifungal drug

Drug: BSG005 or placebo

Placebo

PLACEBO COMPARATOR

Will be a 5% glucose infusion

Drug: BSG005 or placebo

Interventions

BSG005 or placebo DRUG

SAD part is a single IV infusion of ascending doses of BSG005 or placebo - a 30 minutes infusion that may be extended to 2 hours if infusion reactions occur. The MAD part is single daily infusions of the cohort dose over 30 minutes (that may be delayed up to 2 hours in case of infusion reactions) and which will be repeated daily for 7 days. Objective is safety, tolerability and PK on day 1 and day 7 and to establish steady state plasma level.

Also known as: BSG005, Placebo

BSG005; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only males as repro tox is only ongoing.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be included in this study, each individual must satisfy all the following criteria:
• Male adult subjects aged 18 - 55 years at screening.
• Subjects without concurrent illnesses who do not require any medical treatments.
• Judged by an Investigator to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), 12-lead ECG, vital sign assessments, clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the Investigator(s) and/or judged to be not clinically significant for study participation.
• Body Mass Index ≥18 and \<30 kg/m2 and a weight of at least 50 kg.
• Negative drug and alcohol screen in urine. Negative pregnancy test (females)
• Subject is a non-smoker or smokes ≤ 10 cigarettes per day (or equivalent).
• Must be able and willing to provide written informed consent.
• Are willing to remain in the study unit for the entire duration of the treatment period, attend all scheduled visits, and comply with all study procedures.
• If sexually active males, must use a condom OR abstinence OR same sex partner OR surgically sterile OR partner is of non-childbearing potential.

You may not qualify if:

• If an individual meets any of the following criteria, he or she is ineligible for this study:
• Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device.
• Any clinical evidence that the Investigator feels would place the subject at increased risk with the investigational product.
• Subject shows clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, or clinical laboratory parameters for the screening assessments (especially for liver enzymes, and serum creatinine and estimated creatinine clearance) according to the Investigator's judgment.
• Has liver enzyme results (AST, ALT, GGT) above the upper normal limit (UNL): AST 37 U/L; ALT 78 U/L; GGT 55 U/L.
• Has a creatinine value outside the normal range (female \<0.51 mg/dL; male \<0.67 mg/dL) and an estimated creatinine clearance (Cockcroft-Gault) \< 30 mL/min
• Subject with, or history of clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
• Subject who has a sitting or lying blood pressure at screening, after resting for at least 5 minutes: systolic blood pressure \> 155 or \< 90 mmHg, or diastolic blood pressure \> 90 or \< 40 mmHg.
• Subject who has a sitting or lying pulse rate at screening, after resting for at least 5 minutes, outside the range of \< 39 or \> 101 beats/min.
• Subject who donated blood or who had a comparable blood loss (approximately 500 mL) during the last 30 days prior to start of this study.
• Subject with a known history of clinically significant drug allergies in the opinion of the Investigator or with a known allergy to any medicine chemically related to the study medication.
• Subject who has had a clinically significant illness within four weeks prior to screening in the opinion of the Investigator.
• Subject with a history of chronic alcohol (regular daily intake of more than, e.g., three standard drinks) or drug abuse within the last 6 months prior to first administration or evidence of such abuse as indicated by the laboratory profile conducted during the screening examination.
• Subject who has received prescription drugs or OTC medication other than dietary supplements, occasional ibuprofen, standard dose vitamins, or herbal products within 2 weeks prior to the first administration (with the exception of up to 1000 mg acetaminophen per day).
• Subject who plans to take concomitant medications while enrolled in the study (with the exception of up to 1000 mg acetaminophen per day or vitamins, dietary supplements, or herbal products).

Sponsors & Collaborators

• Biosergen AS: lead
• Select Pharma Pty Ltd: collaborator
• Greenlight Clinical: collaborator
• Nucleus Network Ltd: collaborator

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Philippe Ryan, MD

  Nucleus Network, Melbourne site, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peder M Andersen, MD

CONTACT

+45 20802470; peder.andersen@biosergen.net

Tine K Olesen, PhD

CONTACT

+4531355707; Tine.olesen@biosergen.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: DB and placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single escalation dose safety, tolerability and PK followed by multiple escalation dose for safety, tolerability and PK.

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: June 10, 2021
• Study Start: August 23, 2021
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)